VACCINE DEVELOPMENT IN INDIA
VACCINE DEVELOPMENT IN INDIA
Vaccines are important preventive medicines for primary health care and are a critical component of a nation’s health security. Although international agencies such as the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) promote global immunization drives and policies, the success of an immunisation programme in any country depends more upon local realities and national policies. This is particularly true for a huge and diverse developing country like India, with its population of more than one billion people, and 25 million new births every year.
The current Indian market for vaccines is estimated to be about US$260 million. India is among the major buyers and makers of vaccines, locally as well as globally, and has traditionally aimed at self-reliance in vaccine technologies and production.
The history of vaccine research and production in India is almost as old as the history of vaccines themselves. During the later half of the 19th century, when institutions for vaccine development and production were taking root in the Western world, the British rulers in India, concerned by the large number of their personnel dying from tropical diseases, promoted research on these diseases and established about fifteen vaccine institutes beginning in the 1890s. Prior to the establishment of these institutions, there were no dedicated organisations for medical research in India.
Haffkine’s development of the world’s first plague vaccine in 1897 (which he developed at the Plague Laboratory (Mumbai, India), later named the Haffkine Institute) and Manson’s development of an indigenous cholera vaccine at Kolkata during the same period bear testimony to the benefits of the early institutionalisation of vaccine research and development in India.
However, the benefits of this early institutionalization did not last long. The policies of the colonial government ensured that Indian scientists were not a significant part of this intellectual legacy. By the time Indians inherited the leadership of the above institutions in the early 20th century, research and technological innovation were sidelined as demands for routine vaccine production took priority. By the time India gained independence in 1947, the Indian vaccine research and development (R&D) institutions were no longer on a par with vaccine technology development centres elsewhere. This is reflected in the fact that improved techniques for bacterial vaccines were introduced in India almost a decade after their introduction elsewhere in the world.
VACCINE POLICY IN INDEPENDENT INDIA
One year after its independence in 1947, India became a member country of the WHO and eagerly aligned itself to the policies of the WHO and UNICEF. Many new Indian institutions were established with partial support from international organisations during the period 1950-1970.
However, after independence, it took three decades for India to articulate its first official policy for childhood vaccination, a policy that was in alignment with the WHO’s policy of “Health for All by 2000” (famously announced in 1978 at Alma Atta, Kazakhstan). The WHO’s policy recommended universal immunisation of all children to reduce child mortality under its Expanded Programme of Immunisation (EPI). In line with Health for All by 2000, in 1978 India introduced six childhood vaccines (Bacillus Calmette-Guerin, TT, DPT, DT, polio, and typhoid) in its EPI. Measles vaccine was added much later, in 1985, when the Indian government launched the Universal Immunisation Programme (UIP) and a mission to achieve immunisation coverage of all children and pregnant women by thel990s.
GAPS IN VACCINE TECHNOLOGY AND PRODUCTION
Vaccine requirements for India’s EPI have been met mainly through the public-sector vaccine institutions, as was the case in most parts of the world until the 1980s. However, the Indian public sector failed to introduce new technologies of production (such as production of TT, DT, or DTP) or to expand production to become self- reliant in producing Oral Polio Vaccine (OPV) or the measles vaccine. Thus, even though successive governments have adopted self-reliance in vaccine technology and self-sufficiency in vaccine production as policy objectives in theory, the growing gap between demand and supply meant that in practice, India had increasingly to resort to imports.
One of the main reasons for the growing gap in demand for and supply of primary vaccines in India is that while public sector production is on the decline, vaccine availability from the private sector or through the UNICEF procurement mechanism has not improved.
Shortages of primary vaccines in developing countries began to emerge in the late 1990s. These shortages were due to the introduction of new, more sophisticated, more expensive vaccines in industrialised country markets, leading to manufacturers phasing out the production of the traditional, less expensive vaccines used in developing countries. Between 1998 and 2001, ten out of 14 major manufacturers partially or totally stopped production of traditional vaccines. Eight of these firms were the main suppliers of vaccines to UNICEF.
Therefore, India (and indeed, every country) must evolve its own national strategies to meet its vaccination needs within its budgetary constraints. To do so will require three key actions.The first and foremost element in this strategy must be the strengthening the public sector wherever possible, or by taking suitable (and transparent) measures to encourage the indigenous private sector on a case-by-case basis to make safe and effective vaccines available at affordable prices.
Secondly, a strong emphasis on in- house R&D is needed in order to ensure that our production technologies are in tune with the times, and to negotiate strategic partnerships with outside scientists or institutions and companies.
Central Research Institute, Kausoli, HP
Established on 3 May 1905 by Dr David Sample to develop vaccines. In 1911, Dr Sample first developed a rabies tissue vaccine from the brains of sheep deliberately infected and then killed.
The institute performs large-scale production of bacterial and viral vaccines and serum. It has developed DPT, DT, tetanus, cholera, and typhoid vaccines, and is the only producer in India of rabies vaccine. It also produces snake antivenin.
The institute is an active member of the Influenza Surveillance Program under WHO guidelines. It also has a Polio Vaccine Testing Laboratory, which conducts tests of polio vaccines imported from other countries.
The Quality Control Division of the institute is responsible for testing all products produced by the institute. It works with the Central Drugs Laboratory in the testing of vaccines and serum, which fall under the Drugs and Cosmetic Act of 1940. All drug companies in India must have their vaccine or serum tested and approved by this division before they can market it.
Last but not least, the Indian government should actively encourage independent policy research, cost- benefit studies, and wider national consultations on various aspects of vaccination and public health so that it can take more informed decisions on such matters.